T/FDSA 0101-2025 Active Group standards

T/FDSA 0101-2025 Glycan chain detection kit (fluorescent capillary electrophoresis method)

Publish Date: 2025-11-10 Implement Date: 2025-12-10 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/FDSA 0101-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Biological products and blood products

ICS Name: Surgical instruments and materials

Publish Date: 2025-11-10

Implement Date: 2025-12-10

Scope

This document specifies the requirements, testing methods, labels, user manuals, packaging, transportation, and storage for oligosaccharide chain detection kits (fluorescence capillary electrophoresis method). This document is applicable to kits used for detecting oligosaccharide chains in human blood samples (whole blood, serum, plasma, etc.) by fluorescence capillary electrophoresis (hereinafter referred to as the kits). For other methods such as time-resolved fluorescence analysis, the guidelines can be used as a reference for implementation.